BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LATITUDE ELBOW PROSTHESIS

    MDR report key: 6125344 · Received November 23, 2016

    Report

    Report Number
    3004983210-2016-00051
    Event Type
    Injury
    Date Received
    November 23, 2016
    Report Date
    October 28, 2016
    Manufacturer
    TORNIER INC.
    Product Code
    JDB
    PMA / PMN Number
    K100562
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS IS THE FINAL REPORT SUBMITTED REGARDING THIS SURGICAL EVENT AND MEDICAL DEVICE. LITERATURE REFERENCE: ELBOW HEMIARTHROPLASTY FOR THE MANAGEMENT OF DISTAL HUMERAL FRACTURES: CURRENT TECHNIQUE, INDICATIONS AND RESULTS. JOIDEEP PHADNIS, ADAM C WATTS, GREGORY I BAIN; SHOULDER & ELBOW 2016, VOL. 8(3) 171-183.

    Description of Event or Problem · 1

    IT WAS REPORTED IN THE LITERATURE THAT THE FOLLOWING LATITUDE CONCOMITANT COMPLICATIONS OCCURRED: 4 PATIENTS HAD METALWORK REMOVED DUE TO OLECRANON OSTEOTOMY, 2 PATIENT HAD A PERIPROSTHETIC FRACTURE, 1 PATIENT HAD ULNAR NEVER IRRITATION REQUIRING SUBSEQUENT SURGERY, 6 PATIENTS HAD ULNAR NEVER IRRITATION NOT REQUIRING SUBSEQUENT SURGERY, 2 PATIENT HAD INFECTION (NO LISTED INTERVENTION), 20 PATIENT HAD HETEROSCOPIC OSSIFICATION, 1 PATIENT HAD HETEROSCOPIC OSSIFICATION WITH SURGICAL INTERVENTION, 1 ASEPTIC LOOSENING REQUIRING REVISION, 1 LATERAL COLLATERAL RECONSTRUCTION FOR POSTEROLATERAL ROTATORY INSTABILITY, AND 1 RADIO-ULNAR SYNOSTOSIS. THESE COMPLICATIONS WERE NOT REPORTED TO BE DIRECTLY RELATED TO THE LATITUDE PROSTHESIS. NO FURTHER PATIENT COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    777238 LATITUDE ELBOW PROSTHESIS ELBOW PROSTHESIS JDB TORNIER INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention